Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: A randomized controlled trial

Charmaine E. Lok, Louise Moist, Brenda R. Hemmelgarn, Marcello Tonelli, Miguel A. Vazquez, Marc Dorval, Matthew Oliver, Sandra Donnelly, Michael Allon, Kenneth Stanley

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

Context: Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. Objective: To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. Design, Setting, and Participants: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation. Interventions: Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. Main Outcome Measure Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. Results: The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P=.06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P<.001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P<.001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P<.001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P=.04]); and lower mean systolic blood pressure (-3.61 vs 4.49mmHg; difference, -8.10 [95% CI, -15.4 to -0.85]; P=.01). Conclusions: Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. Trial Registration: isrctn.org Identifier: ISRCTN15838383.

Original languageEnglish (US)
Pages (from-to)1809-1816
Number of pages8
JournalJAMA - Journal of the American Medical Association
Volume307
Issue number17
DOIs
StatePublished - May 2 2012

Fingerprint

Fish Oils
Renal Dialysis
Randomized Controlled Trials
Transplants
Thrombosis
Capsules
Incidence
Pathologic Constriction
Placebos
Blood Pressure
Controlled Clinical Trials
Chronic Renal Insufficiency
Disease-Free Survival
Blood Vessels
Dialysis
Eating
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts : A randomized controlled trial. / Lok, Charmaine E.; Moist, Louise; Hemmelgarn, Brenda R.; Tonelli, Marcello; Vazquez, Miguel A.; Dorval, Marc; Oliver, Matthew; Donnelly, Sandra; Allon, Michael; Stanley, Kenneth.

In: JAMA - Journal of the American Medical Association, Vol. 307, No. 17, 02.05.2012, p. 1809-1816.

Research output: Contribution to journalArticle

Lok, Charmaine E. ; Moist, Louise ; Hemmelgarn, Brenda R. ; Tonelli, Marcello ; Vazquez, Miguel A. ; Dorval, Marc ; Oliver, Matthew ; Donnelly, Sandra ; Allon, Michael ; Stanley, Kenneth. / Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts : A randomized controlled trial. In: JAMA - Journal of the American Medical Association. 2012 ; Vol. 307, No. 17. pp. 1809-1816.
@article{9d52a321d1e74ebea7c765d0b3a798a9,
title = "Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: A randomized controlled trial",
abstract = "Context: Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. Objective: To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. Design, Setting, and Participants: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50{\%} women, 63{\%} white, 53{\%} with diabetes), with follow-up for 12 months after graft creation. Interventions: Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. Main Outcome Measure Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. Results: The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48{\%}] vs 60/97 [62{\%}], respectively; relative risk, 0.78 [95{\%} CI, 0.60 to 1.03; P=.06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95{\%} CI, 0.44 to 0.75; P<.001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95{\%} CI, 0.35 to 0.72; P<.001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95{\%} CI, 0.44 to 0.78; P<.001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95{\%} CI, 0.19 to 0.96; P=.04]); and lower mean systolic blood pressure (-3.61 vs 4.49mmHg; difference, -8.10 [95{\%} CI, -15.4 to -0.85]; P=.01). Conclusions: Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. Trial Registration: isrctn.org Identifier: ISRCTN15838383.",
author = "Lok, {Charmaine E.} and Louise Moist and Hemmelgarn, {Brenda R.} and Marcello Tonelli and Vazquez, {Miguel A.} and Marc Dorval and Matthew Oliver and Sandra Donnelly and Michael Allon and Kenneth Stanley",
year = "2012",
month = "5",
day = "2",
doi = "10.1001/jama.2012.3473",
language = "English (US)",
volume = "307",
pages = "1809--1816",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "17",

}

TY - JOUR

T1 - Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts

T2 - A randomized controlled trial

AU - Lok, Charmaine E.

AU - Moist, Louise

AU - Hemmelgarn, Brenda R.

AU - Tonelli, Marcello

AU - Vazquez, Miguel A.

AU - Dorval, Marc

AU - Oliver, Matthew

AU - Donnelly, Sandra

AU - Allon, Michael

AU - Stanley, Kenneth

PY - 2012/5/2

Y1 - 2012/5/2

N2 - Context: Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. Objective: To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. Design, Setting, and Participants: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation. Interventions: Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. Main Outcome Measure Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. Results: The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P=.06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P<.001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P<.001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P<.001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P=.04]); and lower mean systolic blood pressure (-3.61 vs 4.49mmHg; difference, -8.10 [95% CI, -15.4 to -0.85]; P=.01). Conclusions: Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. Trial Registration: isrctn.org Identifier: ISRCTN15838383.

AB - Context: Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. Objective: To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. Design, Setting, and Participants: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation. Interventions: Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. Main Outcome Measure Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. Results: The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P=.06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P<.001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P<.001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P<.001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P=.04]); and lower mean systolic blood pressure (-3.61 vs 4.49mmHg; difference, -8.10 [95% CI, -15.4 to -0.85]; P=.01). Conclusions: Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. Trial Registration: isrctn.org Identifier: ISRCTN15838383.

UR - http://www.scopus.com/inward/record.url?scp=84860429667&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84860429667&partnerID=8YFLogxK

U2 - 10.1001/jama.2012.3473

DO - 10.1001/jama.2012.3473

M3 - Article

C2 - 22550196

AN - SCOPUS:84860429667

VL - 307

SP - 1809

EP - 1816

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0098-7484

IS - 17

ER -